Director, Quality Control

Job description

POSITION SUMMARY: The Director, Quality Control provides strategic and operational leadership for all Quality Control (QC) activities supporting drug substance (DS) and dug product (DP) manufacturing at the site. This role is accountable for ensuing the generation of accurate, reliable, and compliant analytical data to support product release, stability, and lifecycle management in accordance with global GMP requirements. The Director QC oversees all QC functions, including analytical, microbiological, and environmental monitoring programs, and ensures alignment with the overall control strategy. This role ensures inspection readiness data integrity, and continuous improvement of QC systems and processes. As a member of the site Quality Leadership Team, the Director partners cross-functionally with Manufacturing m QA, MSAT, AS&T, and Regulatory to support clinical and commercial manufacturing while advancing quality culture and operational excellence. POSITION RESPONSIBILITIES: Provide strategic leadership and oversight of all QC activities supporting DS and DP manufacturing, including release testing, stability programs, and in-process testing. Partner with AS&T to ensure the robu...